Tissue Preservation and Biobanking

Oxford University Hospital Cell and Tissue Biobank (OCTB) now provides a range of tissues for research purposes e.g., fertility tissue from patients undergoing sterilizing cancer treatment and neurological tissue from deceased patients. This development into bio banking domain has posed new challenges. Very few people in UK register as donors who exasperate coordinators asking emotional cancer patients/parents or bereaved families for consent (consent is therefore recorded). Areas of public concern are discussed (e.g., use of tissue in animal studies) and these options are therefore more often declined. Oxford re-consent donors when they become 18. Oxford has also overcome issue of collection of brain/spinal cord from patients who don’t have mental capacity to consent. OCTB is within UK National Health Service (not-for-profit) therefore direct/indirect payment to donors is unacceptable. Payments for use of facility (mortuary/theatres) or staff performing tissue

retrievals is problematical. Reimbursement of costs to biobank following tissue release is difficult to estimate and may not be affordable to researchers. Agreements set up between tissue bank and researchers to confirm ethical, research study approval, sponsors restrictions. Publication acknowledgement, patent ownership and secrecy issues with private funded projects pose

difficulties (UK competent authority must review validation documentation). Legal, quality and safety framework is enforced across Europe but harmonization of operational/ethical issues is ongoing. Oxford has comprehensive quality management system and undergoes annual inspection and licensing. Tissues are directly distributed by OCTB without patient identifiable details. Feedback is not given to donors/bereaved families, even if something medically beneficial is established. All tissues are traceable from donor to end user using single European code and bar coding. Marketing of tissues/cells is authorized in theUK. Oxford is registered in UK tissue biobank directory without a price list. These details could decrease goodwill of donors, increase bad publicity, encourage nefarious trading. Commercial distributors are licensed in the UK, numbers increase as demand increases. General public not yet alerted to this trading. Final costs of tissues released are not controlled or capped in the UK. There are no schemes to monitor/measure needs of researchers. Oxford only permits export if donor was offered this option during consent interview. The Oxford multidisciplinary teams meet regularly to discuss ethical and operational issues. Service review with patients/parents and bereaved relatives is invaluable. This approach has enabled the rapid development of OCTB biobanking service.